Michael Hamrell headshot

QA Q&A Corner: The Mysterious and Sometimes Maddening Form FDA 1572

In this issue's column, the questions raise a number of issues regarding the use of the U.S. Food and Drug Administration (FDA) Form 1572, otherwise known as the "Statement of Investigator" form. Although the form has been in use for many years, it continues to generate a variety of Good Clinical Practice (GCP) compliance–related questions. […]

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Guest Editor’s Message: The Necessity of Workforce Development for Clinical Research Professionals

Jim Kremidas, executive director of the Association of Clinical Research Professionals, has stated that, due to the lack of a standardized path into the clinical research enterprise, there is a "tremendous amount of variance in research conduct, processes, and workforce competence, which culminates in a detriment to research quality."1 His statement hits home […]